Personalized PRRT of Neuroendocrine Tumors (P-PRRT)
Neuroendocrine Tumors, Carcinoid Tumor, Carcinoma, Neuroendocrine
About this trial
This is an interventional treatment trial for Neuroendocrine Tumors focused on measuring Neuroendocrine tumors, Personalized, Peptide receptor radionuclide therapy, PRRT, 177Lu-DOTATATE, 177Lu-octreotate
Eligibility Criteria
Inclusion Criteria:
- Patient suffering from a progressive and/or symptomatic NET (any site);
- Patient ineligible to, or refusing a potentially curative treatment such as surgical resection;
- Patient who did not respond, is intolerant or refuses other indicated and available palliative treatments;
- Demonstration of overexpression of somatostatin receptor by tumor lesions by scintigraphic imaging (Octreoscan or 68Ga positron emission tomography.
Exclusion Criteria:
- Pregnancy;
- Breastfeeding;.
- Very limited survival prognosis (i.e. less than a few weeks, because of the NET disease or any other condition) or Eastern Cooperative Oncology Group (ECOG) 4 performance status;
- Inability to obtain informed consent of the participant.
Sites / Locations
- CHU de Québec - Université LavalRecruiting
Arms of the Study
Arm 1
Experimental
Personalized PRRT (P-PRRT)
177Lu-Octreotate (LuTate) P-PRRT will be administered as follows: Renal absorbed radiation dose will be prescribed for the 4-cycle induction course (23 Gy) and for each subsequent cycle (6 Gy), with a reduction in cases of impaired renal or bone marrow function, or significant toxicity from prior cycles. The personalized activity to be administered at each cycle will be derived from renal dose per unit of injected activity that is predicted by patient characteristics or renal dose delivered during prior cycle(s). Participants responding to the induction course of P-PRRT will be eligible to receive additional consolidation and/or maintenance cycles. Participants with prior PRRT exposure outside the trial may receive less induction cycles, or only consolidation/maintenance cycle(s).